The term “pelvic floor dysfunction” refers to a group of medical conditions generally related to organs and nerves of the pelvic floor area of the body. Some of these conditions include, but are not limited to urinary incontinence, urinary frequency, eneurisis, urethral syndrome, bladder neck disorder, bladder stones, reflux, prostate disorders, anal incontinence, encopresis, orchalgia, pelvic organ prolapse, sexual dysfunction, anal fissures, hemorrhoids, prostatodynia conditions, RUTI (recurrent urinary tract infection), chronic constipation syndromes, IC (intersticial cystitis), pelvic pain syndromes, vulvadynia and spastic colon. This list is not intended to be exhaustive. Instead, this list is intended to convey a number of conditions related to the nerves and organs of the pelvic floor area.
Pelvic floor dysfunction medical conditions are relatively common. For example, the National Institutes of Health (NIH) estimates that at least one-third of adult women are affected by at least one of these conditions.
Medical conditions resulting from pelvic floor dysfunction produce symptoms that often are embarrassing and uncomfortable. As a result, people with pelvic floor dysfunctions are often very uncomfortable talking about or seeking treatment for their condition. Their medical condition itself coupled with their reluctance to seek medical help often results in a lessened quality of life for the person with the medical condition and a lessened quality of life for their friends and families.
As stated, one example of a pelvic floor dysfunction medical condition is urinary incontinence. Urinary incontinence is the involuntary release of urine. The NIH estimates that 13 million people in the US experience urinary incontinence. Their studies show that women experience urinary incontinence twice as often as men. Further, older women are more likely to experience urinary incontinence than younger women. Urinary incontinence may result from many causes including neurogenic diseases such as multiple sclerosis, Parkinson's disease or Alzheimer's disease, strokes, brain tumors, congenital birth defects, weakening of pelvic floor muscles due to childbirth, injuries from accidents or as a side effect of medication or surgery.
Urinary incontinence manifests itself in at least the following ways: stress incontinence (the most common form of urinary incontinence); urge incontinence; overflow incontinence; total incontinence and enuresis. Stress incontinence is the leakage of urine when coughing, sneezing, laughing, jogging or doing anything that causes the person's abdominal pressure to be greater than the bladder's closure mechanism.
Urge incontinence is a sudden, strong desire to urinate along with a sudden, uncontrollable rush or leakage of urine. People suffering with urge incontinence may experience these symptoms at any time. For example, urge incontinence may manifest itself at any time during the day while doing normal activities or during sleep. Further, urinary incontinence may manifest itself after doing such innocuous tasks as drinking a small amount of water, touching water or hearing water running, as for example, when hearing someone else take a shower or wash dishes.
In 1998, T. H. Wagner and T. W. Hu estimated the cost of urinary incontinence for individuals 65 years and older in the US alone at $26.3 billion. This amounts to a cost of $3565 per individual with urinary incontinence or about $95 for every US inhabitant! (Wagner, T. H. and Hu, T. W., Economic Costs of Urinary Incontinence in 1995, UROLOGY, March, 1998, p 355-61).
Another pelvic floor dysfunction medical condition is anal incontinence. Anal incontinence is the inability to control bowel movements. Anal incontinence can manifest itself as the involuntary and unwanted passage of gas, liquid or solid stool. The overall prevalence of fecal incontinence has been reported to approach 20 percent. Further, between 12 and 39 percent of women following childbirth reported fecal or flatal incontinence.
Although specific pelvic floor dysfunction medical conditions have been mentioned above, the invention and its description relate to any and all conditions of the pelvic floor region involving nerve activity.
The terminal part of the human intestines is shown in FIG. 1 generally labeled 2. The terminal part 2 comprises a rectum 4 and an anal canal 6. Anal canal 6 begins at the anal verge 8 and continues into the body until reaching the submucous space 10. The anal crypt 12 is located at the terminal part 2 near the beginning of the submucous space 10. Physiologically, there is a groove 14 at the anal crypt 12.
Rectum 4 begins at the anal canal 6. A sphincter 16 surrounds the hemorrhoidal plexus 18 and puts pressure on the hemorroidal plexus 18 to form a seal at the base of the anal canal 6. The hemorroidal plexus 18 extends inwardly from the sphincter 16. Immediately “upstream” from the hemorroidal plexus 18, rectum 4 widens at 20.
The levator ani muscles 22 generally run from the front to back of the pubic bone 24 and helps to form the pelvic floor (FIG. 2). The levator ani muscles 22 provides support for the structures of the terminal part 2.
The rectum 4 contains a series of rectal valves: the inferior rectal valve 26, the middle rectal valve 28 and the superior rectal valve 30. These rectal valves 26, 28 and 30 are essentially folds in the inner surface of the rectum 4 and extend inwardly from the inner surface of the rectum 4. The inferior and superior rectal valves 26, 30 are located on one side of the rectum 4 while the middle rectal valve 28 is on the opposite side of the rectum 4 than are the inferior and superior rectal valves 26, 30.
As shown in FIG. 3, the pelvis and lower pelvic region is primarily innervated by sacral nerves, and more specifically the S2, S3 and S4 sacral nerves 32, 34 and 36, respectively. Both nerve impulses coming from nerve receptors in the pelvic region (afferent nerve impulses) and nerve impulses going to muscles and organs in the lower pelvic region (efferent nerve impulses) pass through sacral nerves 32, 34 and 36. In particular, it has been found that efferent nerve impulses through the sacral nerves 32, 34 and 36 affect the proper operation of the organs and systems of the pelvis and lower pelvic region including the urinary and fecal systems.
Skin tissue generally and specifically outside the submucous space 10 has karetin in it. As a result, the impedance of this tissue is quite hugh. This renders it difficult to detect electrical activity related to the nerve or muscle activity in the pelvic floor by recording electrodes placed on the skin.
Tissue in the anal canal 6 above the submucous space 10 does not have karetin in it. Consequently, the impedance of this tissue is relatively low compared to skin tissue. Therefore, it should be easier to detect electrical activity related to the nerve or muscle activity in the pelvic floor through recording electrodes placed on the surface of this tissue than it is to detect electrical activity through skin.
It is believed that many problems with such systems stem from improper nerve interaction with muscles and organs associated with the urinary and fecal systems. It would be highly desirable to be able to assess the condition of the nerves of the pelvic floor including the sacral nerves and the conduction of efferent and afferent nerve signals through the nerves of the pelvic floor.